JPRN-UMIN000002518
已完成
1 期
Hybrid biotherapy involving autologous human cardiac stem cell transplantation combined with the controlled release of bFGF using a gelatin hydrogel sheet to treat severe refractory heart failure with chronic ischemic cardiomyopathy - AutoLogous human CArdiac-Derived stem cell to treat Ischemic cArdiomyopathy (ALCADIA)
Kyoto Prefectural University School of Medicine0 个研究点目标入组 6 人2009年10月1日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- severe refractory heart failure with chronic ischemic cardiomyopathy
- 发起方
- Kyoto Prefectural University School of Medicine
- 入组人数
- 6
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- 未提供
排除标准
- •1\)New onset of myocardial infarction or unstable angina within 28 days prior to study entry 2\)Indication for surgical ventricular reconstruction or mitral valve repair \*1 3\)Contraindication for endomyocardial biopsy \*2 4\)Evidence for malignant disease within 3 years prior to study entry 5\)Chronic hemodialysis 6\)Liver Cirrhosis (ICGR 15\>30%) 7\)Uncontrollable diabetes mellitus (HbA1c\>8\.0\) 8\)Maximum diameter of Aortic aneurysm more than 5cm(including dissecting aneurysm) 9\)Cardiogenic shock 10\)Active infection (including cytomegalovirus infection) 11\)Drug or alcoholic dependency 12\)Positive for HIV antigen 13\)Active bleeding state (gastric ulcer, cerebral bleeding, etc.) 14\)Gelatin allergy \*3 15\)Chromosomal abnormality \*1an indication for LV aneurysmectomy; patients with over 2 segments of dyskinesis area \*2contra\-indication for endomyocardial biopsy 1 cardiogenic shock 2 end\-stage or uncontrollable congestive heart failure without continues infusion of catecholamine 3 complete or mobitz type AV block \*3The screening of gelatin allergy is necessary for all patients by gelatin patch test and gelatin\-IgE
结局指标
主要结局
未指定
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